MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY PDX, INTEGRATED SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87222
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between the pd therapy with the liberty pdx cycler/liberty pdx cycler set and the patient¿s peritonitis.However, there is no allegation nor any objective evidence that a liberty pdx cycler/liberty pdx cycler set malfunction or product deficiency was associated with this event.The exact cause of the patient¿s peritonitis cannot be determined with the information available.However, the patient¿s pd effluent yielded growth of streptococcus gordonii which is an organism found in dental plaque.Peritonitis caused by this organism may come from the oral cavity and poor dental hygiene.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient had peritonitis and out of precaution they requested a replacement cycler.However, there were no reported allegations of a liberty pdx cycler/liberty pd x cycler set malfunction or deficiency associated with the peritonitis event.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the pd registered nurse (pdrn) stated that on (b)(6) 2019 the patient was experiencing abdominal pain and cloudy effluent.As a result, the patient went to the outpatient pd clinic and a pd effluent culture was obtained.The cell culture yielded growth of the bacteria streptococcus gordonii.The patient was treated with gentamycin 1500 mg and vancomycin 1.5 grams intra-peritoneal (ip) on an outpatient basis.Per the pdrn, the patient is recovering from the event.There was no identified cause for the event.The nurse indicated they do not believe the peritonitis was caused by the use of a fresenius device, drug, or product.The patient has received the replacement cycler and has been completing pd therapy without any further reported issues.The patient¿s cycler was scheduled to be returned for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY PDX, INTEGRATED SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9270523
• Report Number: 8030665-2019-01692
• Device Sequence Number: 1872567
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-87222
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/02/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR